[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"graft--versus-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:graft--versus-host-disease":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100615846","phase-2-framework-for-optimizing-refining-and-unifying-management-of-hsct-in-pediatric-all-100615846",false,"NCT07297914","Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL","FORUM2","Inclusion criteria applicable to all substudies\n\n* Male and female patients with allogenic transplant indication for ALL, as determined by national frontline protocols\n* Age ≥3 months to ≤25 years at the time of HSCT.\n* Patients must be in complete remission (with \\\u003C5% blasts and absence of leukemia cells in extramedullary sites) prior to undergoing HSCT.\n* Selected donor must be either a matched donor (matched donor category includes 9\u002F10 identical siblings and 10\u002F10 or 9\u002F10 HLA-matched unrelated donors) or a mismatched family donor (≤8\u002F10 HLA match). Either bone marrow or peripheral blood stem cell grafts are permitted. Cord blood is permitted, as well, provided that the unit is at least 6\u002F8 HLA matched and with a cryopreserved cellularity of at least 3x107 nucleated cells\u002FKg recipient body weight.\n* Female patients of childbearing potential must have a negative pregnancy test at screening, and all patients must agree to adhere to effective contraception during the study period.\n* Written study informed consent and\u002For assent from the patient and\u002For the parent, or guardian\n\nExclusion criteria applicable to all substudies\n\n* Patients \\\u003C 3 months and \\> 25 years of age at the time of HSCT.\n* Patients not in complete morphological remission at the time of enrollment.\n* Patients with an initial diagnosis of Non-Hodgkin Lymphoma (NHL).\n* Patients with ALL as a secondary malignancy.\n* Patients with a history of previous autologous or allogeneic HSCT (prior allogeneic transplantation is permitted for subjects receiving post-transplant interventions, such as those enrolled in the R2 and P1 substudies, provided that this is their first allogeneic HSCT).\n* Female patients who are pregnant or breast feeding.\n* Fertile male or female patients of childbearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of contraception.\n* Active clinically uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no physical or radiographic signs of infection progression are present.\n* Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (e.g. positive HBsAg). Subjects with negative HbsAg and positive total HB core antibody may be included if HBV DNA is undetectable at the time of screening. Subjects who are positive for HCV antibody are eligible only if polymerase chain reaction test is negative for HCV RNA. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment. Prior serology results are acceptable for determining eligibility.\n* Known human immunodeficiency virus infection (HIV).\n* Significant respiratory disease including patients who are on mechanical ventilation or who have resting O2 saturation \\\u003C90% by pulse-oximetry on room-air.\n* Presence of severely impaired renal function (confirmed within 72 hours prior to study treatment start) defined by:\n* Glomerular Filtration Rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 using estimated creatinine clearance calculated by updated bedside Schwartz equation or Cockcroft Gault equation OR\n* Renal dialysis requirement\n* Clinically significant or uncontrolled cardiac disease including any of the following:\n* Uncontrolled hypertension\n* New York Heart Association Class III or IV congestive heart failure\n* Clinically significant cardiac arrhythmias\n* Severe hepatic insufficiency, defined by any of the following:\n* Child-Pugh Class C liver disease\n* AST (aspartate aminotransferase) or ALT (alanine aminotransferase) levels \\> 5 times the upper limit of normal (ULN), unless attributable to GvHD\n* Total bilirubin \\> 3.0 mg\u002FdL, unless attributable to GvHD\n* INR (International Normalized Ratio) ≥ 1.7\n* Clinical evidence of hepatic encephalopathy or ascites\n* Presence of severe concomitant constitutional disease that precludes treatment as per protocol, based on the investigator's judgment. Examples include but are not limited to: Down syndrome with severe comorbidities, significant cardiac malformations, and metabolic disorders affecting treatment feasibility.\n* Underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere participation in the study, pose a significant risk to the patient or interfere with interpretation of study data.\n* Karnofsky or Lansky performance score \\\u003C50%, indicating significant functional impairment.\n* Patients who are unwilling or unable to comply with study procedures, including follow-up requirements and treatment schedules.","ALL","3 Months","25 Years",{"count":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Current therapeutic strategies for high-risk or relapsed ALL patients often involve intensive treatments, including allogeneic hematopoietic stem cell transplantation (HSCT). HSCT remains a cornerstone of therapy, offering curative potential; however, it is associated with considerable risks, including non-relapse mortality (NRM), significant morbidity, and long-term complications that continue to be major concerns.\n\nIn response to these challenges, the FORUM consortium has made substantial progress in improving outcomes for children with ALL undergoing HSCT. The consortium focuses on reducing life-threatening and lifelong complications, ultimately aiming to enhance quality of life for these high-risk patients. Building on the robust evidence generated by FORUM1, the FORUM2 study has been designed to further optimize the role of HSCT in ALL across all age groups and donor settings within a harmonized and internationally coordinated framework.\n\nThe FORUM2 study introduces a master protocol structure that encompasses multiple hypothesis-driven substudies, each addressing a specific determinant of HSCT outcomes. This design enables simultaneous or sequential evaluation of novel strategies while ensuring uniform governance, endpoint definitions, and data-quality standards. The overarching objective is to refine the role of HSCT in ALL by reducing treatment-related toxicity while preserving the essential graft-versus-leukemia effect.",[28,29,30],"Acute Lymphoblastic Leukemia (ALL)","Stem Cell Transplant","Graft -Versus-host-disease","NOT_YET_RECRUITING","2025-12-17",{"date":34,"type":35},"2025-12-22","ACTUAL",{"date":37,"type":21},"2026-01-15",{"date":39,"type":21},"2032-12-01",{"name":41,"class":42},"Bambino Gesù Hospital and Research Institute","OTHER",9,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100611857","phase-2-bpc2001-for-the-prevention-of-acute-graft-versus-host-disease-following-haploidentical-stem-cell-transplantation-100611857","NCT07246031","BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation","An Open-Label, Single-Arm, Phase Ⅱb Clinical Study of BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation","Inclusion Criteria:\n\n1. Male or female ages ≥18 and ≤ 65 years.\n2. Before the start of the trial, the subject or his\u002Fher guardian is sufficient to understand and voluntarily sign the written informed consent form (ICF).\n3. Subjects have a hematologic malignancy as defined below and are considered candidates for haplo-SCT:\n\n   1. Acute leukemia with morphologic complete remission (acute myelogenous leukemia \\[AML\\] or acute lymphoblastic leukemia \\[ALL\\]);\n   2. Myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myeloproliferative neoplasm (MPN) with \\\u003C 10% blasts in the bone marrow.\n4. Organ function tolerated for transplantation:\n\n   1. Cardiac function: Left ventricular ejection fraction at rest ≥ 45%;\n   2. Liver function: Total bilirubin \\\u003C 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 × ULN. Subjects who have been diagnosed with Gilbert's syndrome or malignant disease involvement are allowed to have a total bilirubin value \\> 1.5 × ULN;\n   3. Serum creatine \\\u003C 2 mg\u002FdL or estimated creatinine clearance \\> 50 mL\u002Fmin calculated using the Cockcroft-Gault equation；\n   4. Pulmonary function tests (PFTs): diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) and\u002For forced expiratory volume in 1 second (FEV1) ≥ 50%.\n5. Subject is suitable for myeloablative haplotype related donor transplant.\n6. Subject is suitable for receiving first alloHSCT.\n7. The transplant donor must meet the following criteria:\n\n   1. Donor ages \\> 30 years; If the donor ages is equal to or less than 30 years, the donor should be female for male subject;\n   2. High-resolution typing of human leukocyte antigen (HLA)-A, -B, -C, DR, and DQ are matched at least 5\u002F10;\n   3. Meet the criteria for peripheral blood stem cell (PBSC) donation;\n   4. Donor's specific antibodies are negative, \\\u003C2,000 MFI.\n8. Source of allografts: using G-CSF as the mobilizing agent to mobilize PBSC transplant; bone marrow or cord blood is not allowed.\n9. Karnofsky Performance Status (KPS) score ≥ 60 points.\n10. Is a Candidate for anti-GvHD prophylaxis, including ATG, calcineurin inhibitor (CsA or tacrolimus \\[FK 506\\]) in combination with MTX and MMF.\n11. Female subjects of childbearing potential must have a negative serum pregnancy test prior to enrollment and must have agreed to use a double barrier method of contraception from the time of signing the ICF to 90 days after the last dose of investigational drug.\n12. Male subjects must agree to use effective contraception from the time of signing the ICF to 90 days after the last dose of investigational drug.\n\nExclusion Criteria:\n\nAny subjects who meet any of the following criteria will be excluded from study entry:\n\n1. Has had any other prior organ transplantation.\n2. Planned use of any additional or alternative drugs for GvHD prophylaxis than listed in the inclusion criteria.\n3. Has had received an investigational drug within 4 half-lives or within 14 days prior to HSCT, whichever is longer; or plans to participate in another clinical study prior to completion of all scheduled evaluations in this clinical study.\n4. Has other malignancies that are not controlled.\n5. Has evidence of active central nervous system (CNS) disease.\n6. Patients with uncontrolled active bacterial, viral, or fungal infections.\n7. Known history of human immunodeficiency virus (HIV) or positive HIV antibody test.\n8. Hepatitis B virus surface antigen (HBsAg) or hepatitis B virus core antibody (HBcAb) is positive, and the hepatitis B virus (HBV) DNA in peripheral blood is above the limit of quantification; or hepatitis C virus (HCV) antibody and peripheral HCV RNA are positive; or the syphilis TRUST test is positive.\n9. Pregnant or lactating females.\n10. Has undergone major surgery within 1 month prior to the first dose of investigational drug.\n11. In the opinion of the investigator, the subject has any other medical condition that renders the subject unsuitable for participation in the study.\n12. Has a history of uncontrolled autoimmune disease or on active treatment.\n13. Vaccinated with live or attenuated vaccine within 4 weeks prior to the first dose of investigational drug.\n14. History of myocardial infarction, unstable angina, acute coronary syndrome, congestive heart failure (New York Heart Society classification ≥ class Ⅲ), or clinically significant arrhythmia within 6 months prior to receiving the investigational drug.\n15. Plan to use prophylaxis donor lymphocyte infusion (DLI) therapy.\n16. The transplant donor is the subject's mother or collateral relative.","18 Years","65 Years",{"count":54,"type":21},50,[24],"A Phase IIb open label study evaluates the safety and efficacy of repeat doses of BPC2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Haploidentical Stem Cell Transplantation (Haplo-SCT).",[30,58,59,60],"aGVHD","Haploidentical Stem Cell Transplantation","cGVHD",[62,63,64,65,66],"aGvHD","Haplo-SCT","BPC2001","BioPhoenix","KRN-7000","RECRUITING","2025-11-20",{"date":70,"type":35},"2025-11-24",{"date":72,"type":35},"2025-10-29",{"date":74,"type":21},"2028-02-28",{"name":76,"class":77},"BioPhoenix Co., Ltd.","INDUSTRY",1]